Biofeedback Training in Patients With Advanced Lung Cancer - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Number of patients that are able to return for eight visits of BFSM
研究概览
简要总结
This is a pilot study to test the hypothesis that biofeedback-mediated stress management (BFSM) training can be used to reduce distress and enhance quality of life in patients with non-small cell lung cancer (NSCLC). Most patients with advanced NSCLC have significant physical symptoms, but even those who do not have physical symptoms have high levels of anxiety and depression.
详细描述
Biofeedback-mediated stress management (BFSM) involves helping patients to visualize the reactions which their own bodies have to stressful situations (increased heart rate, increased skin conductance, increased muscle tension, decreased digital peripheral temperature, decreased heart rate variability) and then teaching them to control these reactions, using standard stress management and relaxation techniques, coupled with computerized physiological feedback. The feedback helps patients to understand that deep relaxation is helping their bodies as well as their minds. Several small studies of BFSM training in cancer populations have been successful at helping with side effects of chemotherapy and radiation, but the effects of BFSM on distress and quality of life (QOL), particularly in NSCLC patients, have not been studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a new diagnosis of advanced (stage IV) non-small cell lung cancer (NSCLC)
- •ECOG performance status 0-
- •Plan to receive care at the Taussig Cancer Center.
排除标准
- •Non-local patients, who will not have the ability to return for 8 study visits.
- •Patients who are unable to speak and understand English readily,
- •Patients with significant cognitive impairment.
结局指标
主要结局
Number of patients that are able to return for eight visits of BFSM
时间窗: 16 weeks
Keep track of how many visits the patients attend, how many they cancel, and what other difficulties are encounter in getting them to return for eight visits.
次要结局
- Change in baseline of skin conductance(16 weeks)
- Change from baseline on the FACT-lung questionnaire(16 weeks)
- Change in baseline of digital peripheral temperature(16 weeks)
- Change from baseline of the Patient Health Questionnaire (PHQ-*8)(16 weeks)
- Number of patients able to complete the Quality of Life (QOL) questionnaires(16 weeks)
- Assess changes in distress thermometer from baseline(16 weeks)
- Change from baseline of the Hospital Anxiety and Depression Scale (HADS)(16 weeks)
- Change from baseline of Electromyography (EMG)(16 weeks)
- Change from baseline of respiratory rates(16 weeks)
- Change from baseline of heart rates(16 weeks)